Clinical Trial Associate, APAC
Core
Support the planning, coordination, and execution of Phase I-III insourced global clinical studies within the oncology portfolio.
Role type
Clinical Trial Associate (Oncology)
Builds
Global clinical studies for novel oncology treatments
Domain
Biopharmaceuticals / Oncology
Deliverable
client delivery
Required skills
Clinical trial regulations (ICH-GCP, FDA), CTMS/EDC systems, study document management, site selection and feasibility, investigator meeting coordination, trial supply logistics, data query resolution, TMF maintenance, patient recruitment tracking, regulatory compliance
Preferred skills
Previous experience as Clinical Trials Associate or Study Coordinator in pharma/biotech/CRO, knowledge of oncology clinical trials
Technologies
CTMS, EDC, Microsoft Office Suite
Responsibilities
Prepare and maintain study protocols, informed consent forms, and case report forms; coordinate site selection and ethics committee submissions; manage distribution and reconciliation of investigational products; assist in resolving data queries in EDC systems; maintain trial master files; support site monitoring visits; track patient recruitment and enrollment; ensure adherence to study timelines and regulatory guidelines
Seniority
Entry to Mid-level, hands-on IC